A Phase 3b Study of Erythropoietin Drugs Using a Specified Dosing Algorithm in Patients With Chronic Kidney Disease on Hemodialysis

Exclusion Criteria

• •Subjects that meet any of the following criteria will be ineligible to be entered into the interventional cohort:
• •1. Subjects unable to provide a signed and dated informed consent for this clinical research study.
• •2. As determined by the Investigator, female subjects of child bearing potential who do not agree to use a highly effective method of contraception.
• •3. Any condition as determined by the investigator that would place a subject at an increased risk, or preclude subject's full compliance with the study procedures and visits.
• •4. Female subjects who are known to be or found to be, pregnant or lactating.
• •5. Subjects that are not a candidate for ESA therapies per the label warnings listed in the package insert for Epogen and/or contraindications to Epoetin Hospira listed in the Investigators' Brochure; or have had a known positive test for anti-rhEPO antibodies.
• •6. Treatment with any investigational drug within 30 days prior to randomization and throughout this clinical trial.
• •7. Diagnosed with any concurrent condition that could lead to greater-than-normal loss of blood, including but not limited to:
• •* Menorrhagia, peptic ulcer disease, gastrointestinal bleeding, blood dyscrasia, hemoglobinopathy
• •* Use of anticoagulation therapy, including warfarin with a target international normalized ratio (INR) of 2 or greater Anti-platelet therapy (e.g. aspirin or clopidogrel) is permitted, as is heparin given during hemodialysis. Low-dose warfarin is permitted and defined as the presence of at least two INR values less than or equal to 1.5 during the 120 days prior to enrollment and no values exceeding 1.5 at any time after 120 days prior to enrollment.
• •Subjects started on warfarin with a known INR goal of 2.0 or greater are to receive no further treatment with the study drugs, but follow up visits can continue.
• •Subjects on warfarin who meet criteria to enter the study are terminated if an INR \> 2.0 is discovered or if no INR is available for 60 days.
• •8. History of transfusion of any blood product in the past 3 months, or 2 or more transfusions in the past 1 year; or donated or lost \> 475 mL blood volume (including plasmapheresis) in the past 3 months.
• •9. Subjects currently receiving a long acting ESA, or who have received a long acting ESA in the 16 weeks prior to study randomization